UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Exploratory Cross-sectional Study of Associations between Fatty Acid Metabolism Scintigraphy (123I-BMIPP test) in the Liver of Nonalcoholic Fatty Liver Disease (NAFLD) Patients and Serum Biomarkers and the Degree of Progression of NAFLD Pathology
Title of the study (Brief title)	Exploratory Cross-sectional Study of Associations between Fatty Acid Metabolism Scintigraphy (123I-BMIPP test) in the Liver of Nonalcoholic Fatty Liver Disease (NAFLD) Patients and Serum Biomarkers and the Degree of Progression of NAFLD Pathology
Region	Japan

Condition
Condition	nonalcoholic fatty liver disease
Classification by specialty	Hepato-biliary-pancreatic medicine Endocrinology and Metabolism Radiology Laboratory medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We will explore associations among the degree of pathological progression in the liver of NAFLD patients, BMIPP uptake in the liver by fatty acid scintigraphy, serum markers and several factors associated with lipid metabolism in the liver.
Basic objectives2	Others
Basic objectives -Others	We will explore associations among the degree of pathological progression in the liver of NAFLD patients, BMIPP uptake in the liver by fatty acid scintigraphy, serum markers and several factors associated with lipid metabolism in the liver.
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	We will conduct this study by performing fatty acid scintigraphy in NAFLD patients grouped according to the degree of histopathological progression in the liver and make comparisons between the degrees of BMIPP uptake in the various groups.
Key secondary outcomes	We will comprehensively analyze each factor involved in fatty acid metabolism in each group by using blood serum collected in the fasting state, after a meal, and during fatty acid scintigraphy, and liver tissue. Then we assess their relationships with the disease status.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Medicine Device,equipment
Interventions/Control_1	We will perform fatty acid scintigraphy (123I-BMIPP test).
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	75 years-old >
Gender	Male and Female
Key inclusion criteria	NAFLD patients Patients with a pathological diagnosis of NAFLD based on a liver biopsy within the past 8 weeks Patients from whom consent has been obtained to participate in this study, which has been approved by the ethics committee.
Key exclusion criteria	a. Patients who have any other liver disease, such as chronic hepatitis C, chronic hepatitis B (HBs-Ag-positive patients), autoimmune hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, &#61537;1-antitrypsin deficiency, Wilson disease, or alcohol-related liver disease b. Patients who have a serious hepatic dysfunction, liver failure (encephalopathy, ascites, ruptured varices, or hyperbilirubinemia) c. Patients who have a serious renal dysfunction d. Patients who have a serious cardiopulmonary dysfunction e. Pregnant women, parturient women, breast-feeding women
Target sample size	60

Research contact person
Name of lead principal investigator	Yuichi Nozaki
Organization	National Center for Global Health and Medicine
Division name	Department of Gastroenterology
Address	1-21-1 Toyama, Shinjuku-ku, Tokyo
TEL	03-3202-7181
Email

Public contact
Name of contact person	Yuichi Nozaki
Organization	National Center for Global Health and Medicine
Division name	Department of Gastroenterology
Address	1-21-1 Toyama, Shinjuku-ku, Tokyo
TEL	03-3202-7181
Homepage URL
Email

Sponsor
Institute	National Center for Global Health and Medicine, Department of Gastroenterology
Institute
Department

Funding Source
Organization	National Center for Global Health and Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Kochi University, Department of Gastroenterology
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	国立国際医療研究センター(東京都)

Other administrative information
Date of disclosure of the study information	2013 Year 02 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2012 Year 12 Month 26 Day
Anticipated trial start date	2013 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 01 Month 22 Day
Last modified on	2018 Year 10 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011533